Gynecological ablation procedure and system using an ablation needle

ABSTRACT

A method for treating pelvic tumors, such as uterine leiomyomata, includes inserting an ablation apparatus into a pelvic region and positioning the ablation apparatus either proximate or into a pelvic tumor. The method further includes using a laparoscope and an imaging device, such as an ultrasound machine, to confirm the location of the pelvic tumor and placement of the ablation apparatus. Various ablation apparatuses may be used, including those with multiple needles or deployable arms that are inserted into the pelvic tumor and those without arms. The method further includes delivering electromagnetic energy or other energy through the ablation apparatus to the pelvic tumor to ablate the tumor. A surgical system for ablating pelvic tumors is also provided.

FIELD OF THE INVENTION

[0001] The present invention relates to a procedure and system fortreating gynecological disorders. More particularly, the presentinvention relates to the treatment of pelvic tumors.

BACKGROUND OF THE INVENTION

[0002] Benign and malignant tumors can occur in the pelvis. For example,uterine leiomyomata, are muscle cell tumors that occur in 77% of womenin the reproductive years. Although uterine leiomyomata rarely (0.1%)progress to cancer, these tumors can cause excessive menstrual bleeding,irregular bleeding, pregnancy loss, infertility, urinary frequency, andpelvic pressure or pain with sexual activity, menses, or dailyactivities. Women with uterine leiomyomata frequently incur surgicalprocedures (e.g., hysterectomy, dilatation and curettage, myomectomy,and hysteroscopy), medical and hormonal therapies, office visits, and avariety of radiologic procedures (e.g., ultrasounds, CAT scans, andMRIs), in an effort to treat these tumors. Uterine leiomyomata accountfor approximately 200,000 hysterectomies per year in the United Statesalone, at a direct cost of well over $2 billion. Hysterectomies carry amorbidity rate of 1%, with 2,000 deaths per year and 240,000complications per year in North America.

[0003] Uterine leiomyomata are most often multiple, and may besubserosal (i.e., bulging externally from the uterus), intramural (i.e.,growing entirely within the wall of the uterus), submucosal (i.e.,hidden within the uterine cavity), or pedunculated (i.e., growingoutward with a stalk-like base). Because patients may have multipleuterine leiomyomata at different locations, conservative surgeries mayinvolve both an abdominal and a vaginal (hysteroscopic) approach,thereby necessitating two procedures.

[0004] Investigators have utilized a laser or bipolar cautery to performmyolysis or destruction of these tumors, although neither of thesemethods is performed in significant numbers today. These methodsnecessarily destroy normal overlying tissue in order to treat theunderlying tumor. As a result, the integrity of the uterus iscompromised, and harmful scar tissue (e.g., adhesions) may occur. Thus,there is a need for an improved method of treating benign and malignantpelvic tumors that does not damage the overlying tissue. Such animproved method could be used on women who wish to later conceive andsubsequently deliver. There is also a need for a single method capableof treating all sizes of subserosal, intramural, submucuosal, andpedunculated tumors in all locations. A single method, which wouldrelieve most or all symptoms of abdominal or pelvic pain/pressure,abnormal uterine bleeding, urinary frequency, infertility, andmiscarriage, is also needed. In addition, it would be desirable for themethod to be less invasive, cheaper, and safer than conventional methodsof treating pelvic tumors, and also to allow for uterine preservation.

SUMMARY OF THE INVENTION

[0005] The present invention, also referred to as “the Halt procedure,”is an innovative, outpatient procedure that utilizes electromagneticenergy to effectively ablate pelvic tumors. The invention employs anablation device that uses radio-frequency (RF) energy to treat pelvictumors, while sparing the surrounding normal tissue. Although theablation device utilized in the present invention has FDA approval forablation of soft tissue tumors, no known reports exist in the medicalliterature of the ablation device's application to uterine leiomyomataor other pelvic tumors. In addition, current results indicate that,compared to other conservative therapies, the present method is veryeffective. Thus far, the present invention has provided relief from allof the types of symptoms caused by pelvic tumors, such as uterineleiomyomata. Furthermore, the present invention is versatile, safe, andwell-accepted by patients. Advantages of the present invention include aquick recovery time, typically no more than a week, and significant costsavings. More importantly, the present invention provides a practicaland efficient way to achieve uterine conservation on an out-patientbasis.

[0006] In accordance with one embodiment of the present invention, amethod of treating a pelvic tumor includes inserting an ablation deviceinto a pelvic region and positioning the ablation device proximate thepelvic tumor, using a laparoscope and an imaging device to confirmplacement of the ablation apparatus. Various ablation devices may beused. For example, the ablation device may include no arms, a pluralityof deployable arms, or separate needles that are inserted into thepelvic tumor. The method further includes delivering energy through theablation device to the pelvic tumor to ablate the tumor. The method usesRF energy, however, other forms of energy, such as microwave, light(e.g., laser), or acoustic (e.g., ultrasound) energy may also be used toablate the pelvic tumors.

[0007] In accordance with another embodiment of the present invention, amethod of treating pelvic tumors includes providing a patient on anoperating table, and at least one monitor for a laparoscope and animaging device, with the at least one monitor located across theoperating table from a surgeon and proximate the patient's waist. The atleast one monitor may be mounted on a tower located proximate thepatient's waist. An energy source and the imaging device are providedadjacent to the at least one monitor, with the energy source and imagingdevice being located proximate the patient's knees. The method furtherincludes inserting an ablation device into a pelvic region of thepatient and positioning the device proximate a pelvic tumor. Thelocation and placement of the ablation device with respect to the pelvictumor is confirmed using the laparoscope and the imaging device. Themethod also includes delivering energy to the pelvic tumor to ablate thetumor. The tumor may be maintained at a temperature in the range ofapproximately 65° C. and 100° C. for at least 7 minutes to ablate thetumor.

[0008] In accordance with still another embodiment of the presentinvention, a surgical system for treating pelvic tumors in a patientlying on an operating table includes an ablation device, an energysource, a laparoscope, and an imaging device. The energy source iscoupled to the ablation device and provides energy to the device toablate a pelvic tumor. The laparoscope and the imaging device areconnected to at least one monitor. The at least one monitor is locatedthe operating table from a surgeon and proximate the patient's waist,while the energy source and imaging device are located alongside the atleast one monitor and proximate the patient's knees.

[0009] The present invention procedure may be performed by laparoscopy(i.e., open abdominal incision), percutaneously, or hysteroscopically.The Halt procedure has most often utilized conventional laparoscopy withthe additional placement of (1) a supra-pubic port or sleeve (10 mm) atthe top of the uterus for an intra-abdominal ultrasound probe and (2) anablation device, also usually in the lower abdominal region. The Haltprocedure has also been performed by a trans-abdominal technique,utilizing conventional trans-abdominal ultrasound and placement of theablation device trans-abdominally with laparoscopic confirmation, aswell as by a trans-cervical technique.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1 is a perspective diagram of a surgical system for ablatingpelvic tumors, in accordance with the present invention.

[0011]FIG. 2 is a top plan view of the surgical system of FIG. 1,illustrating an arrangement of certain equipment with respect to apatient lying on an operating table.

[0012]FIG. 3 is a flowchart illustrating a closed laparotomy method ofablating pelvic tumors in accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0013] Referring first to FIG. 1, a surgical system 10 for ablatingpelvic tumors includes a laparoscope 12, a video monitor 14 associatedwith laparoscope 12, an imaging device 16, a video monitor 18 associatedwith imaging device 16, an energy source 20 and an ablation device 22.Laparoscope 12, which is inserted into a patient P, is electricallyconnected to video monitor 14, which displays an image from laparoscope12. As will be explained in greater detail below, laparoscope 12 enablesa surgeon to view the insertion and placement of ablation device 22 intoa pelvic region of the patient.

[0014] Imaging device 16 is electrically connected to video monitor 18and provides images of the patient's pelvic region. These images, whichare displayed on video monitor 18, enable the surgeon to determine thepresence and location of any pelvic tumors. Imaging device 16 shown inFIG. 1 is an ultrasound machine, and includes an intra-abdominalultrasound probe 24. Instead of intra-abdominal ultrasound probe 24, atransducer (not shown) may be coupled to the ultrasound machine fortrans-abdominal ultrasound imaging. In addition, other imaging devices,such as an MRI machine or a CT device, may also be used instead of anultrasound machine.

[0015] Ablation device 22 is a sterile, electrosurgical device that mayinclude a plurality of retractable arms 26. FIG. 1 shows arms 26 ofablation device 22 deployed in a pelvic tumor 28. Examples of theablation device include the Model 30 Electrosurgical Device and theRITA® StarBurst™ XL, both available from RITA Medical Systems, Inc. Eacharm 26 of ablation device 22 is a retractable curved electrode fordelivering energy and has a thermocouple (not shown) located at thedistal end. Although FIG. 1 shows ablation device 22 as includingdeployable arms, an ablation device without any arms may also be used.Alternatively, the ablation device may include two or more needles thatmay be inserted into the tumor.

[0016] Ablation device 22 is coupled to energy source 20, which suppliesenergy to each of the arms 26 of ablation device 22. Energy source 20may be an RF generator, such as the Model 500 Generator or the RITA®Model 1500 RF Generator, both available from RITA Medical Systems, Inc.The supply of RF energy from energy source 20 to ablation device 22 andto a dispersive electrode 30 is controlled by an operator control, suchas by a foot pedal 32. The application of RF energy causes an increasein tumor temperature. At sufficiently high temperatures, cell deathoccurs, thereby destroying the tumor.

[0017] Energy source 20 may further include a mono-polar or bipolarenergy source, which allows the ablation device 22 to utilizetraditional mono-polar or bipolar cautery to treat very small,superficial tumors and to ablate the track formed during insertion ofablation device 22. Cauterizing the ablation device track reduces orprevents bleeding upon withdrawal of ablation device 22 from thepatient.

[0018] As better illustrated in FIG. 2, in accordance with the presentinvention, the equipment of surgical system 10 is set up about thepatient in a non-traditional arrangement. FIG. 2 illustrates the patientP lying in a dorsal position on an operating table 34. A tower 36, whichsupports video monitor 14 for laparoscope 12 and imaging device monitor18, is located proximate the patient's waist, rather than at the foot ofoperating table 34. Since the surgeon S is located on the other side ofoperating table 34 across from tower 36, the surgeon S has a direct viewof the monitors 14 and 18. Video monitors 14 and 18 need not be providedon tower 36; they may be suspended from the ceiling and located on theother side of operating table 34 across from the surgeon S. Duringlonger surgical procedures, the placement of video monitors 14 and 18directly across from the surgeon is more comfortable for the surgeon, asthe surgeon need not turn his/her head toward the foot of operatingtable 34 to view monitors 14 and 18.

[0019] Although FIGS. 1 and 2 show separate video monitors 14 and 18 forlaparoscope 12 and imaging device 16, respectively, a single monitorcapable of simultaneously displaying multiple images from thelaparoscope and the imaging device, such as a picture-in-picturemonitor, may also be used. The single monitor would be located acrossthe table from the surgeon S and may be mounted on tower similar totower 36, suspended from the ceiling, or otherwise located across thepatient from the surgeon for easy viewing by the surgeon.

[0020] Tower 36 may include additional equipment (not shown), such as aninsufflation machine, a printer, and a light source. Tower 36 may beprovided with wheels so that it may be easily moved about the operatingroom. An additional monitor 37 for laparoscope 12 may also be providedacross from a surgical assistant A, who is seated across the table fromthe surgeon S, at approximately the patient's chest level. Thus,additional monitor 37 would be located adjacent the surgeon S.Additional monitor 37 may mounted on a movable tower (not shown),suspended from the ceiling, or otherwise appropriately located.

[0021] Imaging device 16 and energy source 20, which are not located ontower 36, are positioned along operating table 34, across from thesurgeon S, and toward the foot of operating table 34. For example,imaging device 16 and energy source 20 may be located proximate thepatient's knees.

[0022] A method of treating pelvic tumors, in accordance with oneembodiment of the present invention, will now be described, withreference to the flow chart illustrated in FIG. 3. This method 50employs a laparoscopic technique for ablating pelvic tumors. First, atstep 52, the patient is prepared for laparoscopy by placing and properlyadhering dispersive electrode 30 to the lower back of the patient. Atstep 54, the patient is then placed under general anesthesia, and thesurgeon performs an examination of the pelvic region. A manipulator 38(FIG. 1), such as a tenaculum, is placed on the patient's cervix, and a14 french foley catheter is inserted into the patient's bladder foremptying the bladder during the surgical procedure.

[0023] At step 56, the patient is placed in a dorsal position with herarms at her sides, rather than extended out as an airplane, and ablanket and a surgical drape are placed over the patient. This positionprovides the surgeon and surgical assistant with more room to moveabout. The dorsal position is also a safer position for the patient thana frog-leg or lithotomy position, as the dorsal position reduces theinstance of nerve injuries and provides better circulation. In addition,the dorsal position does not require the use of custom drapes andstirrups. The surgical drape contains pouches for at least onelaparoscopic cord. Serial compression devices (not shown) are placed onthe patient's legs to improve circulation during the surgical procedureand reduce the possibility of thromboembolism. In addition, the patientmay be placed in a bear hugger system (not shown) to maintain thepatient's body temperature while under general anesthesia.

[0024] At step 58, the equipment is arranged about operating table 34.As illustrated in FIG. 2, tower 36, which includes video monitors 14 and18, an insufflation machine, a printer and a light source, is placedproximate the patient's waist and across from the surgeon S. Thesurgical assistant A is seated across the table from the surgeon atabout the patient's chest level, with tower 34 located behind theassistant and further toward the foot of operating table 34. Imagingdevice 16 and energy source 20 are situated alongside operating table 34on the same side as the assistant A and toward the foot of operatingtable 34. The additional monitor 37 is positioned across from thesurgical assistant A at about the patient's chest level.

[0025] At step 60, the patient P is placed in a trendelenburg position.The surgeon then makes an infra-umbilical or sub-umbilical incision. Averres needle is then inserted into the incision and into the peritonealcavity. The insufflation machine is then used to insufflate the abdomenwith carbon dioxide gas until the abdominal pressure is approximately 15mm Hg.

[0026] Next, at step 62, a 5 mm trocar and sleeve are inserted throughthe infra-umbilical or sub-umbilical incision. The trocar is thenremoved and laparoscope 12 is inserted into the sleeve. Laparosope 12and monitor 14 are then used to verify correct placement of laparoscope12 within the peritoneal cavity and the absence of any trauma. Thesleeve is attached to the carbon dioxide gas supply and includes a valvefor controlling the abdominal pressure of the peritoneal cavity.

[0027] Steps 60 and 62 discussed above describe a closed laparoscopyprocedure. For those patients, for whom the surgeon feels an openlaparoscopy would be advantageous, the surgeon would make an infra- orsub-umbilical incision and use a combination of blunt and sharpdissection through subcutaneous tissue. The surgeon would then retractthe instruments for exposure. When the fascia is visualized, it isgrasped with one or more clamps, elevated and incised. This provides aview of the peritoneum below, which may be bluntly or sharply incised.An appropriate laparoscopic sleeve is then placed, and the abdomen isinsufflated with carbon dioxide gas. The laparoscope is then insertedinto the sleeve.

[0028] At step 64, the surgeon then uses laparoscope 12, while palpatinga top of the uterine fundus, to determine an optimal location for anintra-abdominal ultrasound probe. The optimal location is generally atthe top of the uterus, rather than supra-pubic. An incision is then madeat this location and a 10 mm trocar and sleeve are inserted. The trocaris removed and ultrasound probe 24 is inserted into the sleeve. By wayof example, the ultrasound probe 24 may be an Aloka model no.UST-5526L-7.5 probe for use with an Aloka model no. SSD140U ultrasoundmachine. Ultrasound probe 24 transmits an image of the pelvic region toultrasound machine 16. The image is displayed on ultrasound videomonitor 18, which is located on tower 36 proximate video monitor 14 forlaparoscope 12. Thus, the surgeon may simultaneously view the images onvideo monitors 14 and 18. As discussed above, a single monitor thatsimultaneously displays images from laparoscope 12 and imaging device 16may be used instead of separate monitors 14 and 18.

[0029] At step 66, the surgeon examines the entire pelvis and abdomen toconfirm the presence or absence of any pathologies. The surgeon alsouses laparoscope 12 and ultrasound probe 24 to visualize any tumors,such as uterine leiomyomata. In particular, the surgeon takes note ofthe number of tumors, and the location and size of each, and comparesthat information with previously acquired data.

[0030] At step 68, the surgeon determines an order for treating thetumors. This order is determined based on the locations of the varioustumors, and whether or not the tumors are accessible from a singlemidline location or require different locations from which to access thetumors. For example, if two tumors are generally along the same track ofablation device 22, the surgeon will first ablate the deeper tumor and,upon retraction of ablation device 22, ablate the remaining tumor. Inaddition, the surgeon may choose to ablate first a portion of the tumorthat is furthest away from the vasculature and work toward thevasculature, or vice versa.

[0031] At step 70, the surgeon tests ablation device 22 to ensure thatit is operating properly. Ablation device 22 is connected to generator20, and proper feedback from the thermocouples, if any, is observed. Inparticular, the surgeon operates foot pedal 32, or any other appropriateoperator control, to activate the supply of RF energy from generator 20and notes an appropriate rise in temperature and any peaks.

[0032] At step 72, if the surgeon decides that all of the tumors areapproachable via a single midline location, the surgeon makes anincision, approximately 2.5 to 3.0 mm long, and inserts ablation device22. Entry of ablation device 22 is observed using laparoscope 12. Thesurgeon uses ultrasound probe 24 to visualize the size and location ofthe tumors with respect to ablation device 22.

[0033] Next, at step 74, the surgeon manipulates the patient's uterususing other techniques to stabilize the uterus.

[0034] At step 76, after the surgeon has stabilized the uterus andlocated the tumors, the surgeon guides ablation device 22 into theuterus and the into a wall of the uterus. The surgeon may guide ablationdevice 22 by changing the position of the uterus relative to ablationdevice 22. In addition, the surgeon may rotate the ablation device forbetter penetration of the uterine wall with less movement of the uterus.Ablation device 22 has a plurality of markings (not shown) that enablethe surgeon to note the depth of penetration of device 22. Confirmationof the location and placement of ablation device 22 are provided by bothlaparoscope 12 and ultrasound probe 24.

[0035] Next, at step 78, the surgeon advances the tip of ablation device22 to an appropriate depth for treating a tumor. In doing so, the needlemakes only a very small puncture. For example, an ablation device havinga needle of 16 gauge may produce a puncture site of approximately 1 mmto 2 mm in diameter. The appropriate depth depends on the size of thetumor. When ablation device 22 has been inserted to the appropriatedepth, arms 26 of ablation device 22 are deployed to the appropriateextent in the tumor 28, as illustrated in FIG. 1. A 30° scope is used toensure that all of the arms 26 remain within the confines of the tumorand do not extend outside of the organ. Arms 26 may effectively anchorablation device 22 in tumor 28.

[0036] At step 80, the surgeon then records a baseline startingtemperature of the tumor. The temperature of the tumor is obtained bythe thermocouples located at the distal ends of arms 26 of ablationdevice 22.

[0037] At step 82, the surgeon then ablates the tumor by supplying RFenergy from generator 20 to ablation device 22. While generator 20 isactivated, it is important to monitor the temperature or impedance ofall parts of the ablation device. If the temperature or impedance forany part of ablation device 22 is abnormal, it could indicate that thatpart of the device is external to the organ.

[0038] RF energy is supplied to the tumor to raise the temperature ofthe tumor, such that it is in the range of between approximately 65° C.and 100° C., for about 14 minutes. Cell death occurs at a temperature ofabout 65° C. However, since these tumors are heterogeneous and,therefore, can differ in density, vasculature and content, a preferredtarget temperature range for ablating pelvic tumors is between 85° C.and 100° C. For small tumors the target time may be betweenapproximately 7 minutes and 14 minutes. One of ordinary skill in theart, however, will appreciate that ablation times of less than 7 minutesmay also be adequate.

[0039] The temperature of the tumor, as provided by the thermocouples,is monitored and recorded at least at a 7 minutes and a 14 minutesinterval. Thus, at least a baseline starting temperature, half-timetemperature, and end-of-ablation-period temperature are recorded foreach tumor. While RF energy is being delivered to the tumor, the surgeonkeeps an eye on the monitors 14 and 18 to ensure that none of the arms26 of ablation device 22 inadvertently extends through the tumor. Theuterus can contract as it is heated, causing arms 26 of ablation device22 to project from the tumor and contact normal tissue, which may bedamaged by the RF energy. When the tumor has been sufficiently ablated,energy source 20 is turned off.

[0040] After each ablation, at step 84 the uterus is irrigated withfluid. The fluid prevents the serosa from drying out as a result of thecarbon dioxide gas that is pumped into the abdomen.

[0041] If the tumor is larger than the ablation field for the givenablation device, then at step 86, the surgeon may need to repositionablation device 22 within another part of the tumor and reapply RFenergy, repeating steps 76 through 84. Thus, if the tumors are greaterin size than the ablation capacity of ablation device 22, multipleapplications of energy, of overlapping ablation areas, may be necessaryto ablate the bulk of the tumor. For tumors less than 3 cm, however, asingle application of the RF energy should be sufficient to ablate thetumor.

[0042] At step 88, the surgeon then repositions ablation device 22 atthe next tumor. The surgeon may leave ablation device 22 in the sametrack, if the next tumor is along the same line of approach. The surgeonwould retract arms 26 and advance or withdraw ablation device 22 asneeded for entry into another tumor. The surgeon would then repeat theablation sequence of step 76 through step 86 described above.

[0043] If the subsequent tumor is in a different location, the surgeonmay retract arms 26 of ablation device 22 and withdraw ablation device22, while applying a mono-polar cautery to reduce or prevent bleedingfrom the ablation device track. Alternatively, rather than completelywithdraw ablation device 22 and re-insert ablation device 22 throughanother incision, repeating steps 72 through 86, the surgeon maywithdraw ablation device 22 until it is only 0.5 cm to 1 cm deep andadjust the uterus until the desired angle of approach is obtained andproperly locating ablation device 22 with ultrasound probe 24 orapplying traction or pushing inward with uterine manipulator 38.

[0044] Small, superficial, subserosal fibroids (e.g., less than 1 cm)may be ablated with a mono-polar cautery at step 90. Bipolar paddles mayalso be used if the fibroid extends from the wall of the uterus.Similarly, if the tumor is pedunculated, the surgeon may treat or incisethe stalk. Mono-polar or bipolar cautery may be applied to subserosal,intramural, and submucuos leiomyomata. In addition, other pelvicpathologies are treated as appropriate.

[0045] After all of the tumors have been ablated, at step 92, thesurgeon confirms hemostasis, withdraws ablation device 22, and applies amono-polar cautery with ablation device 22 to the puncture sites, ifnecessary. A small amount of irrigation fluid may be left in the pelvis.

[0046] Finally, at step 94, documentation, including videotapes,ultrasound photographs, and photographs from the laparoscope areobtained. The sleeves are opened to allow the escape of the carbondioxide gas. The patient is then removed from the trendelenburgposition, and a local anesthetic agent is injected into the incisions.The surgeon then repairs the fascia of the 10 mm incision using anabsorbable suture, S-retractors to facilitate visualization of thefascial edges. Alis™ clamps are used to facilitate grasping forelevating the fascial edges for suturing, re-approximating thesubcutaneous tissue with sutures, closing the skin, and placingSteristrip™ bandages. The surgeon then removes the dispersive electrode30 and examines the surrounding skin.

[0047] The patient is transported to a recovery room, where she willremain until she is tolerating liquids, ambulating with assistance, andvoiding adequately.

[0048] If the patient's uterus is very large (e.g., 16 weeks orgreater), the above-described laparoscopic technique may be lesseffective. Accordingly, a direct trans-abdominal insertion of ablationdevice 22 is performed with laparoscopic confirmation only (e.g., nointra-abdominal ultrasound confirmation). In this method the patient isprepared in the same manner as that described above at step 52. Thesurgeon also performs a pelvic examination, positions the patient,arranges the equipment, forms an infra-umbilical incision, insufflatesthe patient's abdomen, and inserts laparoscope 12, as in step 54 throughto step 62 above. Specifically, the surgeon inspects the abdomen anddocuments the presence or absence of bowel adhesions or other pathologicconditions that would render this method inappropriate.

[0049] Next, the surgeon releases the gas from the patient's abdomen,allowing the abdominal wall to contact an anterior portion of theuterus. A sterile cover drape over a transducer allows fortrans-abdominal ultrasound imaging using a non-sterile transducer (notshown). The ultrasound is used to locate and measure the tumors.

[0050] The surgeon then makes an incision for ablation device 22 andinserts ablation device 22, using abdominal ultrasonography to guide itsinsertion. Ablation device 22 may be inserted percutaneously, ortrans-abdominally, into the tumor in the uterus.

[0051] Ablation device 22 is positioned at a tumor and arms 26 aredeployed in the tumor, just as described above with respect to thelaparoscopic method. Prior to applying RF energy to the tumor, thesurgeon insufflates the abdomen and performs a laparoscopy to confirmthat none of the arms 26 of ablation device 22 extend beyond the uterinetissue.

[0052] The surgeon then applies RF energy to the tumor, in the samemanner as described at step 80 through step 84 above, includingrecording the baseline, half-time, and end-of-ablation-periodtemperatures. The surgeon may use the same approach as described aboveto ablate multiple pelvic tumors. Upon withdrawal of the ablation device22, the surgeon fulgurates the ablation device track with a mono-polarcautery. Thus, remaining steps are the same as step 86 through step 94described above.

[0053] The above-described methods enable the surgeon to ablatesubstantially all of a tumor from a single, ablation device puncturesite. In addition, depending on the location of the tumors, multipletumors may be ablated from a puncture site. The methods further enablethe surgeon to treat all sizes of tumors in any area of the pelvicregion.

[0054] The foregoing description of the preferred embodiments of thepresent invention have been provided for illustrative purposes only.They are not intended to be exhaustive or to limit the invention to theprecise forms disclosed. Various modifications may be made withoutdeparting from the spirit and scope of the inventions as set forth inthe appended claims. For example, although the present invention hasbeen described with respect to the treatment of uterine leiomyomata, thepresent invention may also be used to treat other pelvic tumors, such asthose present in the ovaries. The present invention may be performedusing a trans-cervical technique or a hysteroscopic technique, inaddition to the laparoscopic and trans-abdominal techniques describedabove. The scope of the invention is defined by the following claims.

1-26. (canceled)
 27. A surgical system for ablating pelvic tumors in apatient, the system comprising: an ablation device for insertion into apelvic region of a patient; an energy source coupled to the ablationdevice for providing energy to the ablation device; a laparoscope forinsertion into the patient; and an intra-abdominal imaging probe forobserving a location of the ablation device within the pelvic region ofthe patient.
 28. The surgical system of claim 27, wherein the imagingprobe is an intra-abdominal ultrasound probe.
 29. The surgical system ofclaim 27, wherein the energy source is an RF energy source. 30.(canceled)
 31. The surgical system of claim 27, wherein the imagingprobe is for manipulating a location of the ablation device within thepelvic region of the patient.
 32. The surgical system of claim 27,wherein the energy source is selected from the group consisting of amicrowave energy source, a light energy source, and an acoustic energysource.
 33. The surgical system of claim 27, wherein the laparoscope andthe intra-abdominal imaging probe are operably coupled to at least onemonitor.
 34. The surgical system of claim 33, wherein the at least onemonitor is located along a first side of an operating table, and whereinthe energy source is located adjacent the at least one monitor along thefirst side of the operating table.
 35. The surgical system of claim 34,further comprising a second monitor located along a second side of theoperating table.
 36. The surgical system of claim 34, further comprisingan operator control operably coupled to the energy source and locatedalong a second side of the operating table.
 37. The surgical system ofclaim 36, wherein the operator control is a foot pedal.
 38. A surgicalsystem for ablating pelvic tumors in a patient, the system comprising:an ablation device for insertion into a pelvic region of a patient,wherein the ablation device includes a plurality of electrodes; anenergy source coupled to the ablation device for providing energy to theablation device; a laparoscope for insertion of the plurality ofelectrodes within a pelvic tumor of the patient to avoid contact withnormal tissue outside of the pelvic tumor; and an intra-abdominalimaging probe for observing a location of the plurality of electrodescompletely within the pelvic tumor of the patient.
 39. The surgicalsystem of claim 38, wherein the imaging probe is an intra-abdominalultrasound probe.
 40. The surgical system of claim 38, wherein thelaparoscope and the intra-abdominal imaging probe are operably coupledto at least one monitor, the at least one monitor being located along afirst side of an operating table, and wherein the energy source islocated adjacent the at least one monitor along the first side of theoperating table.
 41. The surgical system of claim 38, wherein the energysource is selected from the group consisting of an RF energy source, amicrowave energy source, a light energy source, and an acoustic energysource.
 42. The surgical system of claim 40, further comprising a secondmonitor located along a second side of the operating table.
 43. Thesurgical system of claim 40, further comprising an operator controloperably coupled to the energy source and located along a second side ofthe operating table.
 44. The surgical system of claim 43, wherein theoperator control is a foot pedal.
 45. A surgical system for ablatingpelvic tumors in a patient, the system comprising: an ablation devicefor insertion into a pelvic region of a patient, wherein the ablationdevice includes a tip and three or more electrodes deployable from thetip; an energy source coupled to the ablation device for providingenergy to the ablation device; a laparoscope for insertion of the threeor more electrodes within a pelvic tumor of the patient to avoid contactwith normal tissue outside of the pelvic tumor; and an intra-abdominalultrasound probe separate from the ablation device for observing alocation of the three or more electrodes completely within the pelvictumor of the patient.
 46. The surgical system of claim 45, wherein thelaparoscope and the intra-abdominal ultrasound probe are operablycoupled to at least one monitor, the at least one monitor being locatedalong a first side of an operating table, and wherein the energy sourceis located adjacent the at least one monitor along the first side of theoperating table.
 47. The surgical system of claim 45, wherein the energysource is selected from the group consisting of an RF energy source, amicrowave energy source, a light energy source, and an acoustic energysource.
 48. A method of treating a pelvic tumor comprising: inserting anablation device into a pelvic region, wherein the ablation deviceincludes at least one electrode; providing the at least one electrodewithin a pelvic tumor; confirming placement of the at least oneelectrode completely within the pelvic tumor with a laparoscope and anintra-abdominal imaging probe separate from the ablation device; anddelivering energy through the at least one electrode to the pelvic tumorto ablate the tumor.
 49. The method of claim 48, wherein the imagingprobe is an intra-abdominal ultrasound probe.
 50. The method of claim48, wherein the pelvic tumor is a uterine fibroid.
 51. The method ofclaim 48, wherein the ablation device includes a plurality of deployablearms.
 52. The method of claim 48, wherein the delivered energy isselected from the group consisting of RF, microwave, light, and acousticenergy.
 53. The method of claim 51, further comprising deploying theplurality of arms completely within the pelvic tumor.
 54. The method ofclaim 48, further comprising manipulating the pelvic region with theintra-abdominal imaging probe to position and stabilize the pelvicregion.